Federal regulations · Through 2026-08-25 · Newer source version available

21 CFR 882.5889: Electrical tongue nerve stimulator to treat motor deficits.

(a) Identification. An electrical tongue nerve stimulator to treat motor deficits is a prescription device that consists of a non-implantable apparatus to generate electrical pulses for stimulation of the nerves in the tongue to provide treatment of motor deficits.
(b) Classification. Class II (special controls). The special controls for this device are:
(1) Performance data must demonstrate that all patient-contacting components of the device are biocompatible.
(2) Performance data must demonstrate the electromagnetic compatibility, battery safety, and electrical, mechanical, and thermal safety of the device.
(3) Non-clinical performance testing must characterize the electrical stimulation parameters of the device.
(4) Software verification, validation, and hazard analysis must be performed. Software documentation must include an assessment of the impact of threats and vulnerabilities on device functionality and end users as part of cybersecurity review.
(5) Labeling must include:
(i) A detailed summary of the device's technical parameters;
(ii) Instructions for use;
(iii) Cleaning, storage, and charging instructions; and
(iv) Disposal instructions.

Where this section sits in the code

Title 21—Food and Drugs
CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER H—MEDICAL DEVICES
PART 882—NEUROLOGICAL DEVICES
Subpart F—Neurological Therapeutic Devices

(b) Classification. Class II (special controls). The special controls for this device are:

(1) Performance data must demonstrate that all patient-contacting components of the device are biocompatible.

(2) Performance data must demonstrate the electromagnetic compatibility, battery safety, and electrical, mechanical, and thermal safety of the device.

(3) Non-clinical performance testing must characterize the electrical stimulation parameters of the device.

(4) Software verification, validation, and hazard analysis must be performed. Software documentation must include an assessment of the impact of threats and vulnerabilities on device functionality and end users as part of cybersecurity review.

(5) Labeling must include:

(i) A detailed summary of the device's technical parameters;

(ii) Instructions for use;

(iii) Cleaning, storage, and charging instructions; and

(iv) Disposal instructions.

Collected 2026-08-27T02:24:47Z. Source file · JSON

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